Clinical trial · Interventional
GENe EXpression After Regional or General ANesthesia in Patients Undergoing Breast Cancer Surgery
GENe EXpression in Tissues From Operating Field After Regional or General ANesthesia in Patients Undergoing Breast Cancer Surgery. The GENEXAN Randomized Controlled Genomic Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breast cancer is the most commonly diagnosed cancer in females and the second leading cause of death from cancer in women. It was estimated that 2 million new cases have occurred in 2018 worldwide 1. Standard anesthetic procedures for the surgery of breast cancer include general and regional anesthesia 2. Growing preclinical and clinical data support the hypothesis that anesthetic choice may affect cancer-related outcomes. Recurrence in breast cancer was reduced to four-fold in a retrospective study with a 2.5 to 4 year follow up 3. Recurrence and metastasis-free survival, with multivariate analysis, was 94% (95% CI 87,100) versus 82% (74, 91) at 24 months, and 94 (87, 100) versus 77 (68, 87) at 36 months in the paravertebral and general anesthesia patients, respectively, (p=0.013). Currently large confirmatory randomized trials evaluating breast cancer recurrence in patients operated with general or regional anesthesia are yet undergoing 4.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General anesthesia | Procedure | — | UNRESOLVED |
| Regional anesthesia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- General anesthesia
- description
- Breast cancer surgery (Tumor Stage 1-3, Nodes 0-2 as determined according to the NCI stage definitions http://www.cancer.gov/cancertopics/pdq/treatment/breast/HealthProfessional/page3/print)
- interventionNames
- Procedure: General anesthesia
- type
- EXPERIMENTAL
- label
- Regional anesthesia
- description
- Breast cancer surgery (Tumor Stage 1-3, Nodes 0-2 as determined according to the NCI stage definitions http://www.cancer.gov/cancertopics/pdq/treatment/breast/HealthProfessional/page3/print)
- interventionNames
- Procedure: Regional anesthesia
Primary outcomes (2)
- measure
- Whole genome expression by microarray
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Women 18-85 years old * No undergoing pregnancy * ASA Score I-IV * Patients scheduled for breast surgery * No contraindications (including surgical) to regional (paravertebral) anesthesia * No previous breast surgery * No known hereditary or familial cancer syndromes * No previous cancer anamnesis, radio o chemiotherapy * Primary breast cancer with Tumor classification 1-3, Nodes 0-2 as determined * according to the NCI stage definitions (Primary breast cancer without known extension beyond the breast and axillary nodes) * Free from pain in preoperative period * Patients who don't use analgesic drugs before surgery * Patients without cognitive impairment or mental retardation Exclusion Criteria: * Women \> 18, \< 85 years old * Pregnancy * ASA Score \> IV * Previous breast surgery * Contraindications to regional anesthesia * Known hereditary or familial cancer syndromes * Previous cancer anamnesis, radio or chemiotherapy * Tumor classification \> 3, Nodes \> 2, M \> 0 as determined according to the NCI stage * definitions * Pain in preoperative period * Use of analgesic drugs before surgery * Cognitive impairment or mental retardation * Patients who did not gave a written informed consent * Undergoing therapy with alpha (doxazosin) or beta blockers.
References
Publications (0)
Data not yet available